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Only administer Feraheme as an intravenous infusion over at least 15 minutes and only when personnel and therapies are immediately available for the treatment of anaphylaxis and other hypersensitivity reactions.

Observe for signs or symptoms of hypersensitivity reactions during and for at least 30 minutes following Feraheme infusion including monitoring of blood pressure and pulse during and after Feraheme administration.

Hypersensitivity reactions have occurred in patients in whom a previous Feraheme dose was tolerated.

Following completion of the controlled phase of the trials, 69 patients received 2 additional 510-mg IV injections of FERAHEME for a total cumulative dose of 2.04 g. On day 35 following the additional injections, 70% of these patients experienced an increase in Hgb and iron parameters (TSAT and ferritin)1

1 g is the most commonly recommended full therapeutic dose of IV iron2,3

FERAHEME was proven to increase mean Hgb in adult IDA patients with CKD who were NDD in 2 pivotal trials vs oral iron1,5,‡,§

Mean Hgb increased by 1.2 g/dL in adult IDA patients with CKD who were NDD1,5,‡

Evaluated in 303 adult IDA patients with CKD stages 1 to 5 who were NDD5

Increase vs baseline at day 35 (P≤0.001)1

TSAT levels1:

FERAHEME 9.8% at baseline and 19.0% at day 35

Oral iron 10.4% at baseline and 10.7% at day 35

‡n values represent the ITT population. Actual n values used in analyses may vary depending on missing values, thus decreasing the n.1§As demonstrated in 2 randomized, active-controlled, open-label pivotal trials in which 303 patients with CKD stages 1 to 5 who were NDD (Trial 1) and 304 patients with CKD stages 1 to 5 who were NDD (Trial 2) were randomized 3:1 to treatment with FERAHEME or oral iron. FERAHEME was administered as two 510-mg doses; most patients received their second FERAHEME injection 3 to 8 days after the first injection. Oral iron (ferrous fumarate) was administered as a total daily dose of 200-mg elemental iron for 21 days.1,5

Diarrhea (4.0%), constipation (2.1%), and hypertension (1.0%) have also been reported in patients treated with FERAHEME.

¶Evaluated in 3 randomized clinical trials in which 605 patients were exposed to 2 injections of 510 mg of FERAHEME and a total of 280 patients were exposed to 200 mg/day of oral iron for 21 days; most patients received their second FERAHEME injection 3 to 8 days after the first injection.1

In a noninferiority study, FERAHEME demonstrated comparable efficacy to iron sucrose in IDA patients with CKD1,6

Only administer Feraheme as an intravenous infusion over at least 15 minutes and only when personnel and therapies are immediately available for the treatment of anaphylaxis and other hypersensitivity reactions.

Observe for signs or symptoms of hypersensitivity reactions during and for at least 30 minutes following Feraheme infusion including monitoring of blood pressure and pulse during and after Feraheme administration.

Hypersensitivity reactions have occurred in patients in whom a previous Feraheme dose was tolerated.

Indication and Dosing

Feraheme is indicated for the treatment of iron deficiency anemia (IDA) in adult patients:

who have intolerance to oral iron or have had unsatisfactory response to oral iron or

who have chronic kidney disease (CKD)

The recommended dose of FERAHEME is an initial 510 mg dose followed by a second 510 mg dose as early as 3 days and up to 8 days later, each dose infused over at least 15 minutes while the patient is in a reclined or semi-reclined position.

Contraindications

Feraheme is contraindicated in patients with known hypersensitivity to Feraheme or any of its components or a history of allergic reaction to any intravenous iron product.

Warnings and Precautions

Hypersensitivity: In addition to the fatal and serious adverse reactions in the Boxed Warning, other adverse reactions associated with hypersensitivity have occurred (pruritus, rash, urticaria, and wheezing). Allergic reactions have occurred following the first dose or subsequent doses in patients in whom a previous dose was tolerated. Patients with a history of multiple drug allergies may have a greater risk of anaphylaxis with parenteral iron products. Carefully consider the potential risks and benefits before administering Feraheme to these patients. Elderly patients with multiple or serious co-morbidities who experience hypersensitivity reactions and/or hypotension following administration of Feraheme may have more severe outcomes.

Hypotension: Feraheme may cause clinically significant hypotension. Monitor patients for signs and symptoms of hypotension following each Feraheme administration.

Iron Overload: Excessive therapy with parenteral iron can lead to excess storage of iron with the possibility of iatrogenic hemosiderosis. Regularly monitor the hematologic response during parenteral iron therapy. Do not administer Feraheme to patients with iron overload.

Magnetic Resonance (MR) Imaging Test Interference: Administration of Feraheme may transiently affect the diagnostic ability of MR imaging. Alteration of MR imaging studies may persist for up to 3 months following the last Feraheme dose. Maximum alteration of vascular MR imaging is anticipated to be evident for 1 – 2 days following Feraheme administration.

You may report an adverse event related to AMAG Pharmaceuticals’ products by calling 1-877-411-2510 or emailing amag@druginfo.com. If you prefer, you may contact the U.S. Food and Drug Administration (FDA) directly at fda.gov/medwatch or call 1-800-FDA-1088.